A new regulatory pathway for personalised therapies based on 'plausible mechanism', which could see therapies authorised after testing on a tiny number of patients, has been revealed by the FDA. FDA ...
The FDA has said it will reduce the regulatory requirements on the manufacturing of cell and gene therapies (CGTs) in order to make it easier for developers to bring them to market. Specifically, the ...
These Q&As cover recent questions about an SDR allocation. For additional background and basic facts please refer to the SDR factsheet. A direct benefit of a general SDR allocation, and indeed the ...
Enzyme mechanisms are the chemical transformations, and the steps within them, generated by enzymatic action on substrates. The mechanism of enzyme catalysis is similar in principle to other types of ...
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